HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD
⚠️ Moderate Risk
FEI: 3016637061 • Yiyang, Hunan • CHINA
FEI Number
3016637061
Location
Yiyang, Hunan
Country
CHINAAddress
Block 5, Comprehensive Industrial Park, Tenghui Pioneer Park, Nanxian Economic Development Zone, Tenghui Pioneer Park ; Nanyang; Economic Development Zone, Yiyang, Hunan, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/21/2021 | 80PXHTHERMOMETER KIT | Division of Northern Border Imports (DNBI) | |
| 4/6/2021 | 80PXHTHERMOMETER KIT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/3/2021 | 80PXHTHERMOMETER KIT | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/26/2021 | 80PXHTHERMOMETER KIT | Division of Southeast Imports (DSEI) | |
| 12/18/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/9/2020 | 80PXHTHERMOMETER KIT | Division of Southeast Imports (DSEI) | |
| 9/4/2020 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Division of Southeast Imports (DSEI) | |
| 8/28/2020 | 80PXHTHERMOMETER KIT | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 8/26/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/21/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/18/2020 | 80PXHTHERMOMETER KIT | Division of West Coast Imports (DWCI) | |
| 8/7/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/23/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/22/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/16/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/16/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/16/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/14/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/10/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/2/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/2/2020 | 80PXHTHERMOMETER KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD's FDA import refusal history?
HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD (FEI: 3016637061) has 21 FDA import refusal record(s) in our database, spanning from 7/2/2020 to 4/21/2021.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD's FEI number is 3016637061.
What types of violations has HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD received?
HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD come from?
All FDA import refusal data for HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.